Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter (REDUCE AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01710150
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : October 18, 2012
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
University of Pennsylvania

October 11, 2012
October 18, 2012
May 2, 2017
November 2012
August 2014   (Final data collection date for primary outcome measure)
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01710150 on Archive Site
Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death [ Time Frame: 2 years ]
Same as current
Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation. [ Time Frame: 2 years ]
Same as current
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).
The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).
Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Typical Atrial Flutter
  • Risk Factors With Future Development of Atrial Flutter
  • Procedure: CTI ablation alone
  • Procedure: CTI ablation and Pulmonary vein isolation (PVI)
  • Placebo Comparator: CTI ablation only
    subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter
    Intervention: Procedure: CTI ablation alone
  • Active Comparator: CTI ablation and PVI.
    subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.
    Intervention: Procedure: CTI ablation and Pulmonary vein isolation (PVI)
Mohanty S, Natale A, Mohanty P, DI Biase L, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Hao S, Hongo R, Beheiry S, Pelargonio G, Forleo G, Rossillo A, Themistoclakis S, Casella M, Russo AD, Tondo C, Dixit S. Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF). J Cardiovasc Electrophysiol. 2015 Aug;26(8):819-825. doi: 10.1111/jce.12688. Epub 2015 May 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.

Risk factors for predicting future occurrence of AF will include:

  1. prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
  2. LA size > 4.0 cm,
  3. left ventricular ejection fraction (LVEF) ≤ 50%,
  4. hypertension, and/or 5) obstructive sleep apnea.

Exclusion Criteria:

  1. Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
  2. inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
  3. failure to provide informed consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Sanjay Dixit, MD University of Pennsylvania
University of Pennsylvania
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP